EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Background:
- Human immunodeficiency virus (HIV)-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.
- Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.
Objectives:
- To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.
- To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.
Eligibility:
-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.
Design:
- Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
- The lymphoma is evaluated using computed tomography (CT) and positron emission tomography (PET) scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.
- Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends.
- Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.
Full description
Background:
This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to participants with HIV-associated non-Hodgkin's lymphoma (HIV-NHL).
This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles.
Objective:
To assess with 90 percent probability that at least 50 percent of participants treated with short-course EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will be progression free at one year.
Eligibility:
Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse large B cell lymphoma (DLBCL).
HIV+ serology.
All stages (I-IV) of disease.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-4.
Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy.
Age greater than or equal to 18 years.
May not be pregnant or nursing.
May not have received previous rituximab.
Design:
Participants will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond complete remission (CR)/complete response unconfirmed (CRu) by computed tomography (CT) scan of all detectable tumors for a minimum of three and maximum of six cycles. Following cycle 2, CT, positron emission tomography scans (PET), and bone marrow biopsies (if initially positive) will be performed.
At the conclusion of the study, we will estimate whether the number of cycles can be reduced using the paradigm. If the cumulative number of participants to relapse exceeds 25 percent by 6 months, the study will be closed.
Following the completion of chemotherapy, restaging will be performed 2 months following the end of treatment, then every 3 months for one year, every 6 months for one year, then every 12 months until relapse, death, or loss to follow up.
Antiretroviral therapy (ART) will be given concurrently with treatment regimen.
To study the effects of treatment approach on parameters of HIV disease, measurements of cluster of differentiation 4 (CD4) cells and viral loads will be made at baseline and at the completion of therapy, and then 2 months following the end of treatment, and then every 3-6 months for a total of 24 months following chemotherapy.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
- INCLUSION CRITERIA:
Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible.
Human immunodeficiency virus (HIV) + serology.
All stages (I-IV) of disease.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-4
Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g., epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture
Age greater than or equal to 18 years
Laboratory tests (unless impairment due to respective organ involvement by tumor):
- Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min
- Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in participants for whom these abnormalities are felt to be due to protease inhibitor therapy
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x upper limit of normal (ULN) (AST and ALT less than or equal to 6x ULN for participants on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
- Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3)
- Platelet greater than or equal to 75,000/mm(3) (unless impairment due to Immune thrombocytopenic purpura (ITP)
Ability of participant to provide informed consent.
EXCLUSION CRITERIA:
Previous rituximab
Pregnancy or nursing.
- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
Current clinical heart failure or symptomatic ischemic heart disease.
Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R).
- Examples include, but are not limited to:
- Severe Acquired immunodeficiency syndrome (AIDS)-related wasting
- Sever intractable diarrhea
- Active inadequately treated opportunistic infection of the central nervous system (CNS)
- Primary CNS lymphoma
Primary CNS lymphoma
Trial design
Primary purpose
Allocation
Interventional model
Masking
68 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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